NCT07424209 Hypnotic Communication in Cardiology: A Randomized Controlled Trial
| NCT ID | NCT07424209 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Università degli Studi del Piemonte Orientale Amedeo Avogadro |
| Condition | Psychological Distress |
| Study Type | INTERVENTIONAL |
| Enrollment | 306 participants |
| Start Date | 2025-06-09 |
| Primary Completion | 2027-06-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 306 participants in total. It began in 2025-06-09 with a primary completion date of 2027-06-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Undergoing medical procedures, especially surgical ones, is a significant source of emotional stress for patients. Emotions like anxiety, fear, anger, and depression often accompany such experiences and can negatively impact clinical outcomes. Preoperative anxiety, in particular, affects nearly half of all surgical patients and can lead to complications such as hemodynamic instability, increased medication needs, and prolonged recovery times. Managing this emotional distress is therefore a priority. While pharmacological strategies are commonly used, growing attention is being given to non-drug interventions such as music, art, and play therapies. One such technique is hypnotic communication-a method that uses empathetic, suggestion-based language to influence emotional and physical states without formal hypnotic induction. This technique has roots in anesthesiology and has shown promise in reducing pain and anxiety during medical procedures. The proposed study aims to evaluate the effectiveness of hypnotic communication in reducing emotional distress in patients undergoing elective coronary angiography. This will be done through a randomized controlled trial involving 306 adult patients at the Cardiology Unit of the Ospedale degli Infermi in Biella, Italy. Participants will be randomly assigned to either an experimental group receiving hypnotic communication alongside standard care, or a control group receiving standard care only. The hypnotic session, delivered by trained nurses, will begin before the procedure and continue until it ends, following a five-phase structure (pre-induction, induction, core, de-induction, and closure). The primary outcome is the patient's emotional state-specifically stress, anxiety, depression, anger, and need for help-measured before and after the procedure using the Emotion Thermometer Tool. Secondary outcomes include post-procedural pain (measured 15 and 60 minutes after) and patient satisfaction with the communication technique. The study is designed with a type I error rate of 0.05 and 80% statistical power, and recruitment is expected to last 24 months. Data will be anonymized, securely stored, and analyzed using appropriate statistical methods. Ethical approval and informed consent are integral parts of the protocol. By investigating the emotional and clinical impact of hypnotic communication, the study hopes to support its integration into routine care practices, offering a simple, safe, and cost-effective method to enhance patient well-being during invasive procedures.
Eligibility Criteria
Inclusion Criteria: * Adult patients (≥18 years), of both sexes, referred to the Cardiology Unit and scheduled for elective coronary angiography; * Ability to read and understand the Italian language. Exclusion Criteria: * Cognitive impairment or neurodegenerative disorders that may compromise the ability to provide informed consent; * Psychiatric disorders, neurodegenerative diseases, or major depressive states.
Contact & Investigator
Simona Milani, MSN
PRINCIPAL INVESTIGATOR
Azienda Sanitaria Locale Biella
Frequently Asked Questions
Who can join the NCT07424209 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Psychological Distress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07424209 currently recruiting?
Yes, NCT07424209 is actively recruiting participants. Contact the research team at alberto.dalmolin@med.uniupo.it for enrollment information.
Where is the NCT07424209 trial being conducted?
This trial is being conducted at Ponderano, Italy.
Who is sponsoring the NCT07424209 clinical trial?
NCT07424209 is sponsored by Università degli Studi del Piemonte Orientale Amedeo Avogadro. The principal investigator is Simona Milani, MSN at Azienda Sanitaria Locale Biella. The trial plans to enroll 306 participants.